CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report
Signa Architect Nuclear Magnetic Resonance Imaging System recalled
GE Healthcare is recalling Signa Architect Nuclear Magnetic Resonance Imaging System, distributed nationwide in the US. The recall was initiated on 23 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0875-2020
- FDA event ID
- 84655
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2019
- FDA classified
- 28 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 23 Dec 2019 | Recall initiated by company | |
| 28 Jan 2020 | Classified by FDA | +36 days |
| 5 Feb 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Product as listed by the FDA
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Where it was distributed
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Questions about this recall
Why was it recalled?
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Which lots are affected?
Mfg. Lot or Serial # System ID PG75A1700023MR 630DMGMR3T 33-4-1252 312702MR3T 033-4-1005 518262MR750W To be provided 082427210212 To be provided 082427170026 To be provided GON4713311 To be provided M4017073 To be provided EM0601 To be provided O009MR03 To be provided GON4634845
Where was it sold?
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 84655| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Signa Pioneer Nuclear Magnetic Resonance Imaging System recalled | GE Healthcare | Labeling Errors | Nationwide | |
| CLASS II | Signa Premier Nuclear Magnetic Resonance Imaging System recalled | GE Healthcare | Labeling Errors | Nationwide | |
| CLASS II | Signa Vibrant Nuclear Magnetic Resonance Imaging System recalled | GE Healthcare | Labeling Errors | Nationwide |
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